Kornimate/medical-research-clean huggingface dataset:
the australian placental transfusion study (apts): should very pre term babies receive a placental blood transfusion at birth via deferring cord clamping versus standard cord clamping procedures?

Conditions: Preterm Birth

Summary: to establish if placental transfusion, using deferred cord clamping for 60 seconds or more while holding the baby at or below the level of the placenta, will improve survival without disability compared with standard early cord clamping in preterm babies less than 30 weeks of gestation.

most preterm babies have the umbilical cord clamped within 10 seconds of birth. placental transfusion is a simple way of giving the baby extra blood at birth by delaying the clamping of the umbilical cord by 60 seconds or more. there is promising evidence from randomised trials that placental transfusion in babies less than 37 weeks of pregnancy may improve their blood pressure, reduce the number of blood transfusions needed and decrease bleeding into the brain, bowel disease and infection. however, we not know if babies born before 30 weeks of pregnancy benefit or if placental transfusion increases or decreases death or childhood disability. despite this uncertainty more doctors are recommending that all very preterm babies are given a placental transfusion at birth. it is important to find out if placental transfusion does more good than harm, before it becomes even more widely used. the australian placental transfusion study will enrol at least 1600 women who will give birth to babies born less than 30 weeks of gestation. these participants will be randomly assigned to either standard treatment where the umbilical cord is clamped within 10 seconds of birth or a second method where the umbilical cord will be clamped after waiting for 60 seconds or more at birth while the baby is being held below the level of the placenta. the main research question is whether placental transfusion reduces death and disability when the baby is discharged from hospital and into childhood.

Eligibility criteria:
inclusion criteria: women who have a reasonable chance of delivering less than 30 weeks of gestation. informed consent has been received from the parent or guardian. exclusion criteria: no indication or contraindication to placental transfusion, in the view of mother or baby.
effects of a finishing protocol implementation in orthodontic patients

Conditions: Malocclusion

Summary: this study evaluates the effects of a finishing protocol in orthodontic outcomes using abo-ogs scores. patients who finish orthodontic treatment and fulfill the inclusion and exclusion criteria receive a treatment using a finishing protocol and their scores are compare with 40 patients who don't receive a finishing protocol

the phase of finishing is the most demanding and detailed of all phases of the orthodontic treatment. american board of orthodontics- objective grading system is a detailed and objective method that evaluates the quality of the final outcome of orthodontic treatment. in order to evaluate and compare the effects of a protocol implementation on the abo-ogs scores, standardize cast models and pan x-ray from by convenience patients of orthodontic postgraduate program of university of antioquia who finish orthodontic treatment and receive the protocol are digitized, eight variables are evaluate and abo-ogs score is calculate. a comparison with 40 no-protocol abo-ogs scores by convenience-selected patients is done. the protocol includes an educate residents program about finishing problems , an standardized clinical and x-ray assessment , brackets reposition and frequent clinical evaluation. the percentage of the protocol implementation is calculate in every patient and reliability test is make . the descriptive analysis and the abo-ogs score comparison is done by pearson or spearman correlation.

Eligibility criteria:
inclusion criteria: * patients who finish orthodontic treatment by orthodontic criteria * receive finishing protocol * accept and sign inform consent * records ( panoramic xray and cast models) taken immediately or 7 days after orthodontic appliances are remove exclusion criteria: * patients who don't accept being at the study * bad quality records * prosthodontic, periodontic and surgical needs treatment after orthodontic treatment

Keywords: treatment outcomes malocclusion/therapy
virtual reality on pain, fear, and emotional appearance during phlebotomy in pediatric hematology and oncology patients

Conditions: Virtual Reality; Pain, Acute; Pediatric Cancer

Summary: in this study, the effect of virtual reality, which is one of the pain relief methods, on the pain, fear and emotional appearance associated with the procedure, was evaluated in children aged 4-12 years who will undergo phelobotomy in a pediatric hematology and oncology outpatient clinic.

this prospective randomized controlled study was conducted in the pediatric hematology and oncology polyclinic blood collection unit of a university hospital in turkey. patients undergoing phelobotomy were allocated to virtual reality or control groups according to a stratified randomization scheme.

Eligibility criteria:
inclusion criteria: the age range is between 4-12 to apply to the pediatric hematology and oncology outpatient clinic and to have blood taken consent of the child and parent to voluntarily participate in the study the child does not have a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality. exclusion criteria: having a fever (\>37.5c) and severe dehydration before the invasive procedure, the patient was given anagesics.

Keywords: virtual reality phlebotomy pain fear anxiety emotional apperance
the efficacy and safety of the postoperative adjuvant treatment in patients with high-risk stage i endometrial carcinoma

Conditions: Endometrial Neoplasms

Summary: this randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in patients with high risk and stage i endometrial carcinoma.


Eligibility criteria:
inclusion criteria: * figo stage: ⅰ, endometrial carcinoma; * female, chinese women; * initial treatment is staging surgery; * pathological diagnosis: endometrial adenocarcinoma; * pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: g3; ② ≥50% myometrial invasion; ③ vascular space involvement; * no prior treatment; * provide written informed consent. exclusion criteria: * unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy; * family history of ovarian cancer; * suffering from other malignancies; * concurrently participating in other clinical trials; * unable or unwilling to sign informed consents; * unable or unwilling to abide by protocol.
pharm optimal-hf pilot

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the goal if this pilot randomized controlled trial is to determine the feasibility of conducting and guide the design of a definitive trial of a pharmacist-led, remotely-administered intervention to optimize medications for heart failure (hf) with reduced ejection fraction (hfref) as part of a multidisciplinary hf clinic. both the intervention group and comparator group will receive usual care by the multidisciplinary hf clinic, including standard-of-care clinical pharmacy services. in addition to usual care, participants randomized to the intervention arm will receive co-management of medications by a dedicated study pharmacist with advanced training and expanded scope of practice, with the aim of achieving optimal medical therapy for hfref based on the 2021 canadian cardiovascular society hf guidelines. the intervention will consist of 30-minute remote (telephone) encounters with a clinical pharmacist every 1-2 weeks with the aim of initiating or titrating ≥1 medication per encounter using standard protocols, for an intervention duration of up to 4 months.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form; 2. stated willingness to comply with all study procedures and availability for the duration of the study; 3. age ≥18 years; 4. clinic diagnosis of hf with new york heart association (nyha) functional class 1 to 3 at time of screening; 5. left ventricular ejection fraction (lvef) ≤40% on cardiac imaging performed within 6 months prior to enrolment; 6. willingness to receive medications for the management of hfref; 7. access to necessary resources for participating (telephone ± computer with internet access). exclusion criteria: 1. already receiving target doses of sacubitril-valsartan, evidence-based beta-blocker and a mineralocorticoid receptor antagonist at time of screening; 2. lying/sitting systolic blood pressure \<90 mm hg at time of enrolment; 3. serum potassium ≥5.5 mmol/l at time of enrolment; 4. ≥2 measurements indicating estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m2 within 3 months prior to enrolment; 5. being considered for heart transplant, durable mechanical circulatory support, or intravenous inotropes at time of screening; 6. requiring diuretic dose greater than furosemide 80 mg equivalents or requiring the addition of a thiazide-like diuretic for more than 3 days at time of screening; 7. felt by the multidisciplinary hf clinic team to be unsuitable for the trial (e.g. substance abuse and other psychological disorders, significant language barrier).

Keywords: medication pharmacist pharmaceutical care pharmacotherapy
non invasive mechanical ventilation in acute cardiogenic pulmonary edema

Conditions: Acute Cardiogenic Pulmonary Edema

Summary: cardiogenic pulmonary edema (cpe) is a common medical emergency and noninvasive ventilation (niv) in addition to conventional medical treatment might be beneficial for patients with cpe.

to evaluate the effect of adding continuous positive airway pressure (cpap) or bilevel positive airway pressure (bipap) to standard medical therapy (st) on intensive care unit (icu) stay, hospital stay, mortality, need for endotracheal intubation, partial arterial o2 tension (pao2), intrapulmonary shunt, alveolar-arterial (a-a) oxygen gradient, and cardiac output in patients admitted to the respiratory intensive care unit (icu) or cardiac care unit (ccu) with acute cpe with gas exchange abnormalities and to evaluate the impact of heart failure type on the outcome of different therapeutic schedules.

Eligibility criteria:
inclusion criteria: 1. cpe confirmed radiologically and/or clinically 2. severe acute respiratory failure (partial arterial oxygen (pao2)/fraction of inspired oxygen (fio2) less than 250) 3. dyspnea of sudden onset with respiratory 4. systolic blood pressure \< 180 mmhg exclusion criteria: 1. immediate need for endotracheal intubation: * severe sensorial impairment * shock * ventricular arrhythmias, * life-threatening hypoxia (spo2 \[oxygen saturation as indicated by pulse oximetry\] less than 80% with oxygen) * acute myocardial infarction necessitating thrombolysis * cardiac or respiratory arrest 2. severe chronic renal failure 3. pneumothorax. 4. contraindication of non invasive ventilation (niv)

Keywords: cpe cpap bipap non invasive mechanical ventilation
ak104 with chemotherapy as neoadjuvant and adjuvant therapy for resectable non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: ak104, a tetravalent bispecific antibody targeting pd-1 and ctla-4, is designed to retain the efficacy benefit of combination of pd-1 and ctla-4 and improve on the safety profile of the combination therapy. the aim of this study is to evaluate the efficacy and safety of ak104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage ii-iiia nsclc.


Eligibility criteria:
key inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status of 0 or 1. 2. have previously untreated and pathologically confirmed resectable stage ii-iiia nsclc. 3. have at least one measurable lesion per recist 1.1 assessed by investigator. 4. have adequate organ function. key exclusion criteria: 1. mixed nsclc and small cell lung cancer histology. 2. patients with other active malignancies within 3 years prior to enrollment. 3. known active autoimmune diseases. 4. use of immunosuppressive agents within 14 days prior to the first dose of study treatment. 5. presence of other uncontrolled serious medical conditions.

Keywords: neoadjuvant and adjuvant therapy bispecific antibody
association between mother-infant attunement during interaction and the quality of general movements

Conditions: Premature Birth

Summary: the proposed research has the potential of contributing to the limited empirical literature on the relationship between maternal sensitivity and motor development of preterm infants. if indeed maternal attuned behaviors will be found to be associated with the quality of motor development, such a finding will support the effectiveness of physical therapy in guiding caregivers to attune their holding and touch of preterm infants. we hypothesize that mothers and infants' attunement during observed interaction will be related to the quality of preterm infants' spontaneous movements in the following ways: first, better maternal attunement to the infants needs, and in particular attunement of holding and touch will be associated with better quality of spontaneous movements of the infants. second, more initiations and/or involvement of infants in interaction will be associated with better maternal attunement to the infant. third, more initiations and/or involvement of infants in interaction will be associated with better quality of spontaneous movements and better achievements in developmental milestone. all hypotheses will be examined while controlling for maternal use of ssc method during hospitalization after birth and family demographic backgrounds.

sixty preterm infants at 3-4 months of corrected age and their mothers will be recruited. infants will be evaluated for their spontaneous movements and their developmental milestones achievement, and mothers and infants will be evaluated for their attunement during observed interaction, especially on maternal attunement in holding and touching their infants. mothers will report on demographic background of the family, temperament of their infants and previous skin to skin contact treatment in the neonatal intensive care unit.

Eligibility criteria:
inclusion criteria:preterm infants born between 26-34 weeks of gestation, whose mothers speak and write hebrew fluently. - exclusion criteria:preterm infants who suffer from perinatal asphyxia, genetic or metabolic diseases, necrotizing colitis that requires operation, intra uterine growth retardation, deafness, retinopathy of prematurity (rop) or major congenital defects. -

Keywords: mother-infant interaction general movements preterm infants
a phase i dose escalation study of lbq707 (gimatecan) administered orally twice per week to japanese patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in japanese patients. gimatecan is administered orally twice per week, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.


Eligibility criteria:
inclusion criteria * patients with histological or cytological confirmed advanced solid tumors, which progressed despite standard therapy or for whom no standard therapy exists * life expectancy of at least 3 months * no dysfunction of bone marrow * no major impairment of renal and hepatic function exclusion criteria * gastrointestinal dysfunction, such as gastrectomy or malabsorption syndrome, that could alter absorption of the study drug * receipt of any investigational compound within the 28 days prior to the first dose of study drug, or failure to recover from the side effects of such prior therapy * receipt of other antineoplastic therapy including chemotherapy, hormone therapy, immunotherapy, radiation therapy within the 28 days * patients known to be hiv, or hepatitis b or c viruses positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection * patients with a history of allergies to the camptothecin family of drugs other protocol-defined inclusion/exclusion criteria may apply

Keywords: gimatecan topoisomerase i inhibitor advanced solid tumors
a new successful approach for emmetropic presbyopic patients using intrastromal pocket with smile module

Conditions: Presbyopia

Summary: presbyopia is physiological insufficiency of accommodation associated with the aging of the eye that results in progressively worsening ability to focus clearly on close objects.though presbyopia is a normal change in our eyes as we age, it often is a significant and emotional event because it's a sign of aging that's impossible to ignore and difficult to hide. this defect is usually corrected by using glasses with bifocal power of suitable focal lengths. but some patients don't want to use glasses for correction. in our study purpose is to show that near vision improves and patient satisfaction increases by preparing an intrastromal pocket for emmetropic patients with near vision problems using the smile module.

this study started at 2016 was performed in eye hospital pristina in 82 eyes of 41 patients aged (40-50) with the emmetropic presbyopic complaint.visumax femtosecond laser created the stromal pocket with a diameter 7.60 mm and cap thickness set to 120 μm from corneal surface and with a small opening - 2 mm superior incision at 90° and side cut angle 50°. the pocket was dissected using a blunt spatula. the patients were followed up for one year with distance, intermediate, and near visual acuity, slit lamp, corneal topography, anterior segment optical coherence tomography. uncorrected near visual acuity at 35 cm increased from j7 to j2 in 8 eyes operated on, from j8 to j2 in 7 eyes, and from j6 to j2 in 6 eyes. uncorrected intermediate visual acuity ranged from j4 to j5 at 70 cm, and uncorrected distance visual acuity remained binocular at 20/20. the patients reported satisfaction while reading a book, looking at the phone, and using a computer. no discomfort was observed from the lights while driving at night. we are shaping the surface of the cornea via an introstrımal pocket. we are using the smile module without removing the lenticule, and we are just separating the center of the cap from the top of lenticule in the short term, we have observed increases in spherical aberrations of patients. we also think that corneal shaping has an effect on the presbyopic correction. we will see and analyze the long-term effects by observing them.

Eligibility criteria:
inclusion criteria: * patient not wishing to use glasses * weak accomodation exclusion criteria: * active anterior segment pathology * previous corneal or anterior segment surgery * any infection
efficacy of esoguard on samples collected using esocheck versus egd for the diagnosis of be

Conditions: Barrett Esophagus; Esophageal Adenocarcinoma; Barretts Esophagus With Dysplasia; Barrett's Esophagus Without Dysplasia

Summary: the study will assess the performance of the combined system, i.e., the use of the esoguard assay on cells collected using the esocheck 510(k) cleared device, to detect barrett's esophagus, with and without dysplasia, and/or esophageal adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per acg guidelines.

this is a multicenter, single-arm study designed to assess the operating characteristics of the esoguard diagnostic assay performed on distal esophageal mucosal cells collected using the esocheck cell collection device, compared to the gold standard, for the screening of be with and without dysplasia and for esophageal adenocarcinoma (eac), in patients at high risk for be and for whom a screening egd is indicated according to acg-established criteria.

Eligibility criteria:
inclusion criteria: 1. men aged 50 years old and older 2. ≥5 years either of * gerd symptoms, * gerd treated with proton pump inhibitor (ppi) therapy (whether symptom control is achieved or not), or, * any combination of treated and untreated periods, as long the cumulative total is at least 5 years 3. no solid foods eaten for at least 2 hours prior to esocheck procedure 4. one or more of the following risk factors: 1. caucasian race 2. current or past history of cigarette smoking 3. bmi of at least 30 kg/m2 4. first-degree relative with be or eac - exclusion criteria: 1. history of prior egd procedure 2. inability to provide written informed consent 3. on anti-coagulant drug(s) that cannot be temporarily discontinued 4. known history of esophageal varices or esophageal stricture 5. any contraindication, as deemed in investigator's medical judgment, to undergoing the esocheck procedure, undergoing the egd procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration 6. history of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills 7. oropharyngeal tumor 8. history of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure 9. history of myocardial infarction or cerebrovascular accident within past 6 months 10. history of esophageal motility disorder 11. currently implanted linx device
effectiveness and costs of enhanced cocaine treatments

Conditions: Cocaine Dependence

Summary: the study will evaluate the effectiveness, economic benefits, and costs of voucher reinforcement for cocaine and alcohol abstinence, additional counseling services, and their combination in a sample of cocaine dependent patients receiving outpatient treatment as usual in a community clinic.


Eligibility criteria:
inclusion criteria: * enrollment in an intensive outpatient program (iop) for no more than 1 month * current dsm-iv diagnosis of cocaine dependence (month prior to iop treatment) * 18-65 years of age * ability to provide names of informants to help locate subject for follow-up exclusion criteria: * iv heroin use in last year * acute medical/psychiatric diagnosis that precludes outpatient treatment * inpatient treatment for 6 weeks or more prior to iop treatment * incarceration for 6 months or more prior to iop treatment
18-week add-on to metformin comparison of saxagliptin and sitagliptin in adult patients with type 2 diabetes (t2d)

Conditions: Type 2 Diabetes

Summary: saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. this study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks exclusion criteria: * type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma * insulin therapy within one year * previous treatment with dpp-4 inhibitor

Keywords: type 2 diabetes metformin